Method of closing an opening in a wall of the heart

ABSTRACT

Disclosed is a closure catheter, for closing a tissue opening such as an atrial septal defect, patent foreman ovale, or the left atrial appendage of the heart. The closure catheter carries a plurality of tissue anchors, which may be deployed into tissue surrounding the opening, and used to draw the opening closed. Methods are also disclosed.

[0001] This application is a divisional of application Ser. No.09/444,904 filed on Nov. 22, 1999, which is a continuation-in-part ofApplication Ser. No. 09/399,521, filed Sep. 20, 1999.

[0002] The present invention relates to methods and devices for closinga body lumen, tissue opening, or cavity and, in particular, for closingan atrial septal defect.

BACKGROUND OF THE INVENTION

[0003] Embolic stroke is the nation's third leading killer for adults,and is a major cause of disability. There are over 700,000 strokes peryear in the United States alone. Of these, roughly 100,000 arehemoragic, and 600,000 are ischemic (either due to vessel narrowing orto embolism). The most common cause of embolic stroke emanating from theheart is thrombus formation due to atrial fibrillation. Approximately80,000 strokes per year are attributable to atrial fibrillation. Atrialfibrillation is an arrhythmia of the heart that results in a rapid andchaotic heartbeat that produces lower cardiac output and irregular andturbulent blood flow in the vascular system. There are over five millionpeople worldwide with atrial fibrillation, with about four hundredthousand new cases reported each year. Atrial fibrillation is associatedwith a 500 percent greater risk of stroke due to the condition. Apatient with atrial fibrillation typically has a significantly decreasedquality of life due, in part, to the fear of a stroke, and thepharmaceutical regimen necessary to reduce that risk.

[0004] For patients who develop atrial thrombus from atrialfibrillation, the clot normally occurs in the left atrial appendage(LAA) of the heart. The LAA is a cavity which looks like a small fingeror windsock and which is connected to the lateral wall of the leftatrium between the mitral valve and the root of the left pulmonary vein.The LAA normally contracts with the rest of the left atrium during anormal heart cycle, thus keeping blood from becoming stagnant therein,but often fails to contract with any vigor in patients experiencingatrial fibrillation due to the discoordinate electrical signalsassociated with AF. As a result, thrombus formation is predisposed toform in the stagnant blood within the LAA.

[0005] Blackshear and Odell have reported that of the 1288 patients withnon-rheumatic atrial fibrillation involved in their study, 221 (17%) hadthrombus detected in the left atrium of the heart. Blackshear J L, OdellJ A., Appendage Obliteration to Reduce Stroke in Cardiac SurgicalPatients With Atrial Fibrillation. Ann Thorac. Surg., 1996.61(2):755-9.Of the patients with atrial thrombus, 201 (91%) had the atrial thrombuslocated within the left atrial appendage. The foregoing suggests thatthe elimination or containment of thrombus formed within the LAA ofpatients with atrial fibrillation would significantly reduce theincidence of stroke in those patients.

[0006] Pharmacological therapies for stroke prevention such as oral orsystemic administration of warfarin or the like have been inadequate dueto serious side effects of the medications and lack of patientcompliance in taking the medication. Invasive surgical or thorascopictechniques have been used to obliterate the LAA, however, many patientsare not suitable candidates for such surgical procedures due to acompromised condition or having previously undergone cardiac surgery. Inaddition, the perceived risks of even a thorascopic surgical procedureoften outweigh the potential benefits. See Blackshear and Odell, above.See also Lindsay B D., Obliteration of the Left Atrial Appendage: AConcept Worth Testing, Ann Thorac. Surg., 1996.61(2):515.

[0007] Despite the various efforts in the prior art, there remains aneed for a minimally invasive method and associated devices for reducingthe risk of thrombus formation in the left atrial appendage.

[0008] Other conditions which would benefit from a tissue apertureclosure catheter are tissue openings such as an atrial septal defect. Ingeneral, the heart is divided into four chambers, the two upper beingthe left and right atria and the two lower being the left and rightventricles. The atria are separated from each other by a muscular wall,the interatrial septum, and the ventricles by the interventricularseptum.

[0009] Either congenitally or by acquisition, abnormal openings, holesor shunts can occur between the chambers of the heart or the greatvessels (interatrial and interventricular septal defects or patentductus arteriosus and aorthico-pulmonary window respectively), causingshunting of blood through the opening. The ductus arteriosus is theprenatal canal between the pulmonary artery and the aortic arch whichnormally closes soon after birth. The deformity is usually congenital,resulting from a failure of completion of the formation of the septum,or wall, between the two sides during fetal life when the heart formsfrom a folded tube into a four-chambered, two unit system.

[0010] These deformities can carry significant sequelae. For example,with an atrial septal defect, blood is shunted from the left atrium ofthe heart to the right, producing an over-load of the right heart. Inaddition to left-to-right shunts such as occur in patent ductusarteriosus from the aorta to the pulmonary artery, the left side of theheart has to work harder because some of the blood which it pumps willrecirculate through the lungs instead of going out to the rest of thebody. The ill effects of these lesions usually cause added strain on theheart with ultimate failure if not corrected.

[0011] Previous extracardiac (outside the heart) or intracardiac septaldefects have required relatively extensive surgical techniques forcorrection. To date the most common method of closing intracardiacshunts, such as atrial-septal defects and ventricular-septal defects,entails the relatively drastic technique of open-heart surgery,requiring opening the chest or sternum and diverting the blood from theheart with the use of a cardiopulmonary bypass. The heart is thenopened, the defect is sewn shut by direct suturing with or without apatch of synthetic material (usually of Dacron, Teflon, silk, nylon orpericardium), and then the heart is closed. The patient is then takenoff the cardiopulmonary bypass machine, and then the chest is closed.

[0012] In place of direct suturing, closures of interauricular septaldefects by means of a mechanical prosthesis have been disclosed.

[0013] U.S. Pat. No. 3,874,388 to King, et al. relates to a shunt defectclosure system including a pair of opposed umbrella-like elements lockedtogether in a face to face relationship and delivered by means of acatheter, whereby a defect is closed. U.S. Pat. No. 5,350,399 toErlebacher, et al. relates to a percutaneous arterial puncture sealdevice also including a pair of opposed umbrella-like elements and aninsertion tool.

[0014] U.S. Pat. No. 4,710,192 to Liotta, et al. relates to a vaulteddiaphragm for occlusion in a descending thoracic aorta.

[0015] U.S. Pat. No. 5,108,420 to Marks relates to an aperture occlusiondevice consisting of a wire having an elongated configuration fordelivery to the aperture, and a preprogrammed configuration includingocclusion forming wire segments on each side of the aperture.

[0016] U.S. Pat. No. 4,007,743 to Blake relates to an opening mechanismfor umbrella-like intravascular shunt defect closure device havingfoldable flat ring sections which extend between pivotable struts whenthe device is expanded and fold between the struts when the device iscollapsed.

[0017] Notwithstanding the foregoing, there remains a need for atransluminal method and apparatus for correcting intracardiac septaldefects, which enables a patch to placed across a septal defect toinhibit or prevent the flow of blood therethrough.

SUMMARY OF THE INVENTION

[0018] The present invention provides a closure catheter and methods forclosing an opening in tissue, a body lumen, hollow organ or other bodycavity. The catheter and methods of its use are useful in a variety ofprocedures, such as treating (closing) wounds and naturally orsurgically created apertures or passageways. Applications include, butare not limited to, atrial septal defect closure, patent ductusarteriosis closure, aneurysm isolation and graft and/or bypassanostomosis procedures.

[0019] There is provided in accordance with one aspect of the presentinvention a method of closing an opening in a wall of the heart. Themethod comprises the steps of advancing a catheter through the opening,and deploying at least two suture ends from the catheter and into tissueadjacent the opening. The catheter is retracted from the opening, andthe suture ends are drawn toward each other to reduce the size of theopening. The opening is thereafter secured in the reduced size.

[0020] In one embodiment, the advancing step comprises advancing thecatheter through an atrial septal defect. The deploying step comprisesdeploying at least four suture ends. Preferably, each suture end isprovided with a tissue anchor, and the deploying step comprisesadvancing the tissue anchors into tissue adjacent the opening. Thesecuring step comprises knotting the sutures, clamping the sutures,adhesively bonding the sutures and/or the tissue to retain the openingin the reduced size.

[0021] In accordance with another aspect of the present invention, thereis provided an atrial septal closure catheter. The catheter comprises anelongate flexible body, having a proximal end and a distal end, and alongitudinal axis extending therebetween. At least two supports areprovided on the distal end, the supports moveable from a first positionin which there are substantially parallel with the axis, and a secondposition in which they are inclined with respect to the axis. A controlis provided on the proximal end for moving the supports from the firstposition to the second position. In one embodiment, the supports inclineradially outwardly in the proximal direction when the supports are inthe second position.

[0022] Preferably, the closure catheter comprises at least foursupports, and each support carries at least one anchor. Each anchor ispreferably provided with an anchor suture.

[0023] In accordance with a further aspect of the present invention,there is provided a method for closing an opening in a wall of theheart. The method comprises the steps of providing a catheter having atleast three tissue anchors thereon, each tissue anchor having a suturesecured thereto. The catheter is advanced to the opening in the wall ofthe heart, and the anchors are inclined outwardly from the axis of thecatheter to aim the anchors at tissue surrounding the opening. Theanchors are deployed into tissue surrounding the opening, and thesutures are manipulated to reduce the size of the openings.

[0024] In one embodiment, the deploying the anchors step comprisesdeploying the anchors in a proximal direction. In another embodiment,the deploying the anchors step comprises deploying the anchors in adistal direction.

[0025] In accordance with a further aspect of the present invention,there is provided a closure catheter for closing an atrial septaldefect. The catheter comprises an elongate flexible tubular body, havinga proximal end and a distal end, and a longitudinal axis extendingtherebetween. At least two anchor supports are provided on the distalend, the anchor supports moveable between an axial position in whichthey are substantially parallel with the longitudinal axis, and aninclined position in which they are inclined laterally away from theaxis. A control is provided on the proximal end, for moving the anchorsupports between the axial and the inclined positions. Each anchorsupport has a proximal end and a distal end, and the distal end ispivotably secured to the catheter so that the proximal end moves awayfrom the axis when the anchor support is moved into the inclinedposition.

[0026] In one embodiment, the closure catheter further comprises ananchor in each of the anchor supports. Preferably, from about four toabout 10 anchor supports are each provided with an anchor. Each anchoris preferably connected to a suture.

[0027] In one embodiment, a retention structure is removably carried bythe distal end of the catheter or slideably carried by the suture. Theretention structure is adapted to be distally advanced such that itconstricts around the sutures, thereby securing them in a desiredposition. In one embodiment, the retention structure comprises aslideable knot, such as a Prusik knot.

[0028] Further features and advantages of the present invention willbecome apparent to those of skill in the art in view of the detaileddescription of preferred embodiments which follows, when consideredtogether with the attached drawings and claims.

BRIEF DESCRIPTION OF THE DRAWINGS

[0029]FIG. 1 is an anterior illustration of a heart, with the proximalparts of the great vessels.

[0030]FIG. 2 is a schematic cross section through the heart with atranseptal catheter deployed through the septum and a closure catheterextending into the LAA.

[0031]FIG. 3A is an enlarged perspective view of the distal end of aclosure catheter in accordance with the present invention.

[0032]FIG. 3B is a cross section taken along the lines 3B-3B of FIG. 3A.

[0033]FIG. 4 is a partial cross-sectional view of a tissue anchor andintroducer, positioned within an anchor guide in accordance with thepresent invention.

[0034]FIG. 5 is an exploded view of a tissue anchor and introducer inaccordance with one aspect of the invention.

[0035]FIG. 6A is a schematic illustration of a tissue anchor andintroducer advancing into a tissue surface.

[0036]FIG. 6B is an illustration as in FIG. 6A, with the anchorpositioned within the tissue and the introducer partially retracted.

[0037]FIG. 6C is an illustration as in FIG. 6B, with the introducerfully retracted and the anchor positioned within the tissue.

[0038]FIG. 7 shows a schematic view of a closure catheter disposedwithin the opening of the LAA.

[0039]FIG. 8 is a schematic illustration of the opening of the LAA as inFIG. 7, with the anchor guides in an inclined orientation.

[0040]FIG. 9 is a schematic illustration as in FIG. 8, with tissueanchors deployed from the anchor guides.

[0041]FIG. 10 is a schematic illustration as in FIG. 9, with the anchorguides retracted into an axial orientation.

[0042]FIG. 11 is a schematic illustration as in FIG. 10, with theclosure catheter retracted and the LAA drawn closed using the tissueanchors.

[0043]FIG. 11A is a schematic illustration of the distal tip of adeployment catheter, having an anchor suture loop with a slideableretention structure thereon.

[0044]FIG. 11B is a schematic illustration of a simplified Prusik knot,utilized as a component of the retention structure shown in FIG. 11A.

[0045]FIG. 11C is an enlargement of the retention structure shown inFIG. 11A.

[0046]FIG. 12 is a perspective view of a closure catheter in accordancewith the present invention positioned within a tissue aperture, such asan atrial septal defect.

[0047]FIG. 13 is a side elevational partial cross-section of thecatheter of FIG. 12, in an anchor deployment orientation within theaperture.

[0048]FIG. 14 is a side elevational partial cross-section as in FIG. 13,with the deployment catheter withdrawn from the aperture.

[0049]FIG. 15 is a side elevational cross section through the aperture,which has been closed in accordance with the present invention.

[0050]FIG. 16 is a perspective view of a closure catheter in accordancewith the present invention, carrying an aperture patch.

[0051]FIG. 17 is a cross-sectional view through the catheter of FIG. 16,shown deploying a patch across a tissue aperture.

[0052] FIGS. 18A-18G are alternate tissue anchors for use with theclosure catheter of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

[0053] For simplicity, the present invention will be described primarilyin the context of a left atrial appendage closure procedure. However,the device and methods herein are readily applicable to a wider varietyof closure or attachment procedures, and all such applications arecontemplated by the present inventors. For example, additional heartmuscle procedures such as atrial septal defect closure and patent ductusarteriosis closure are contemplated. Vascular procedures such asisolation or repair of aneurysms, anastomosis of vessel to vessel orvessel to prosthetic tubular graft (e.g., PTFE or Dacron tubes, with orwithout wire support structures as are well known in the art) joints mayalso be accomplished using the devices of the present invention.Attachment of implantable prostheses, such as attachment of the annulusof a prosthetic tissue or mechanical heart valve may be accomplished. Avariety of other tissue openings, lumens, hollow organs and surgicallycreated passageways may be closed, patched or reduced in volume inaccordance with the present invention. For example, an opening in atissue plane may be closed or patched, such as by attaching a fabric ortissue sheet across the opening. In one specific application, the deviceof the present invention is used to anchor a fabric patch to close anatrial septal defect. The target aperture or cavity may be accessedtransluminally (e.g., vascular catheter or endoscope) or through solidtissue, such as transmural, percutaneous or other approach. The presentinvention may also be used in an open surgical procedure such as toclose the left atrial appendage during open heart surgery to correct oraddress a different condition. In another example, the device isadvanced through the percutaneous opening and used to close a vascularpuncture such as a femoral artery access site for a PTA or otherdiagnostic or therapeutic interventional procedure. Adaptation of thedevices and methods disclosed herein to accomplish procedures such asthe foregoing will be apparent to those of skill in the art in view ofthe disclosure herein.

[0054] Referring to FIG. 1, a heart 10 is illustrated to show certainportions including the left ventricle 12, the left atrium 14, the leftatrial appendage (LAA) 16, the pulmonary artery 18, the aorta 20, theright ventricle 22, the right atria 24, and the right atrial appendage26. As is understood in the art, the left atrium 14 is located above theleft ventricle 12 and the two are separated by the mitral valve (notillustrated). The LAA 16 is normally in fluid communication with theleft atrium 14 such that blood flows in and out of the LAA 16 as theheart 10 beats.

[0055] In accordance with the present invention, a closure catheter 38is advanced through the heart and into the LAA. In general, the closurecatheter 38 is adapted to grasp tissue surrounding the opening to theLAA, and retract it radially inwardly to reduce the volume of and/orclose the LAA. The LAA is thereafter secured in its closed orientation,and the closure catheter 38 is removed. Specific aspects of oneembodiment of the closure catheter in accordance with the presentinvention are described in greater detail below.

[0056] The LAA may be accessed through any of a variety of pathways aswill be apparent to those of skill in the art. Transeptal access, ascontemplated by FIG. 2, may be achieved by introducing a transeptalcatheter through the femoral or jugular vein, and transluminallyadvancing the catheter into the right atrium. Once in the right atrium,a long hollow needle with a preformed curve and a sharpened distal tipis forcibly inserted through the fossa ovalis. A radiopaque contrastmedia may then be injected through the needle to allow visualization andensure placement of the needle in the left atrium, as opposed to beingin the pericardial space, aorta, or other undesired location.

[0057] Once the position of the needle in the left atrium is confirmed,the transeptal catheter is advanced into the left atrium. The closurecatheter 38 may then be advanced through the transeptal catheter 30, andsteered or directed into the left atrial appendage. Alternativeapproaches include venous transatrial approaches such as transvascularadvancement through the aorta and the mitral valve. In addition, thedevices of the present invention can be readily adapted for use in anopen heart surgical procedure, although transluminal access is presentlypreferred.

[0058] Thus, referring to FIG. 2, a transeptal catheter 30 has aproximal end 32 and a distal end 34. The distal end 34 of the transeptalcatheter 30 has breached the septum 40 of the patient's heart 10 and isdisposed adjacent the opening 42 of the patient's LAA 16. The distal end36 of a closure catheter 38 extends from the distal end 34 of thetranseptal catheter 30 and into the LAA 16.

[0059] At the proximal end 46 of the transeptal catheter 30, a luerconnector coupled to a hemostasis valve 48 prevents the egress of bloodfrom a central lumen of the transeptal catheter 30. The proximal end 50of the closure catheter 38 extends proximally from the hemostasis valve48. Additional details concerning the use and design of transeptalaccess catheters are well known in the art and will not be discussedfurther herein.

[0060] Referring to FIGS. 2 and 3, the closure catheter 38 thus has aproximal end 50, a distal end 36, and an elongate flexible tubular body52 extending therebetween. The axial length of the closure catheter 38can be varied, depending upon the intended access point and pathway. Fora femoral vein-transeptal approach, the closure catheter 38 generallyhas an axial length within the range of from about 100 cm to about 140cm, and, in one embodiment, about 117 cm.

[0061] The outside diameter of the flexible body 52 can also be varied,depending upon the number of internal lumen and other functionalities aswill be understood by those of skill in the art. In one embodiment, theoutside diameter is about 12 FR (0.156 inches), and closure cathetersare contemplated to have OD's generally within the range of from about0.078 inches to about 0.250 inches. Diameters outside of the above rangemay also be used, provided that the functional consequences of thediameter are acceptable for the intended application of the catheter.

[0062] For example, the lower limit of the outside diameter for tubularbody 52 in a given application will be a function of the number of fluidor other functional lumen contained within the catheter. In addition,tubular body 52 must have sufficient pushability to permit the catheterto be advanced to its target location within the heart without bucklingor undesirable bending. The ability of the tubular body 52 to transmittorque may also be desirable, such as in embodiments in which the tissueanchor deployment guides are not uniformly circumferentially distributedabout the distal end 36 of the catheter. Optimization of the outsidediameter of the catheter, taking into account the flexibility,pushability and torque transmission characteristics can be accomplishedthrough routine experimentation using conventional catheter designtechniques well known to those of skill in the art.

[0063] The flexible body 52 can be manufactured in accordance with anyof a variety of known techniques. In one embodiment, the flexible body52 is extruded from any of a variety of materials such as HDPE, PEBAX,nylon, polyimide, and PEEK. Alternatively, at least a portion or all ofthe length of tubular body 52 may comprise a spring coil, solid walledhypodermic needle or other metal tubing, or braided reinforced wall, asare known in the art.

[0064] The proximal end 50 of the closure catheter 38 is provided with amanifold 51, having a plurality of access ports. Generally, manifold 51is provided with an access port 53 which may be used as a guidewire portin an over the wire embodiment, and a deployment wire port 57.Additional access ports such as a contrast media introduction port 55,or others may be provided as needed, depending upon the functionalrequirements of the catheter.

[0065] The tubular body 52 has at least a first actuator lumen 54, foraxially movably receiving an actuator 56. Actuator 56 extends between aproximal end 64 at about the proximal end of the closure catheter, and adistal end 66 at or near the distal end 36 of the closure catheter 38.The distal end 66 of the actuator 56 is secured to a cap 68. In theillustrated embodiment, the actuator lumen 54 is in communication withthe access port 53 to permit the actuator 56 to extend proximallytherethrough.

[0066] Actuator 56 can have a variety of forms, depending upon theconstruction of the anchor supports 62 on the distal end 36 of theclosure catheter 38. In general, the catheter in the area of the anchorsupports 62 should have a crossing profile of no more than about 14French for transluminal advancement and positioning. However, the anchorsupports must then be capable of directing tissue anchors into the wallof the cavity or lumen which may have an inside diameter on the order ofabout 1.5 cm to about 3 cm in the case of the LAA in an average adult.The device of the present invention can be readily scaled up or downdepending upon the intended use, such as to accommodate a 5 cm to 10 cmcavity in GI tract applications or 5 mm to about 2 cm for vascularapplications. For this purpose, the anchor supports are preferablymoveable between a reduced cross sectional orientation and an enlargedcross sectional orientation to aim at, and, in some embodiments, contactthe target tissue surface.

[0067] One convenient construction to accomplish the foregoing is foreach anchor support 62 to take the form of a lever arm structure whichis pivotably connected at one end to the catheter body. Thisconstruction permits inclination of the anchor support throughout acontinuous range of outside diameters which may be desirable to aim theanchor and accommodate different treatment sites and/or normalanatomical variation within the patient population.

[0068] A laterally moveable anchor support can be moved between an axialorientation and an inclined orientation in a variety of ways. Oneconvenient way is through the use of a pull wire or other actuator whichincreases the diameter of the deployment zone of the catheter inresponse to an axial shortening of fixed length moveable segments asdisclosed in more detail below. For this construction, the actuator willbe under pulling tension during actuation. Any of a variety ofstructures such as polymeric or metal single or multiple strand wires,ribbons or tubes can be used. In the illustrated embodiment, theactuator 56 comprises stainless steel tube, having an outside diameterof about 0.025 inches.

[0069] A pull wire can alternatively be connected to the radiallyoutwardly facing surface and preferably near the distal end of eachanchor support, and each anchor support is hingably attached at itsproximal end to the catheter. Proximal traction on the pull wire willcause the anchor support to incline radially outwardly in the distaldirection, and toward the target tissue.

[0070] In an alternate construction, the anchor support is inclinedunder a compressive force on the actuator 56. For example, theembodiment described in detail below can readily be converted to a pushactuated system by axially immovable fixing the distal end of the anchorguide assembly to the catheter and slideably pushing the proximal end ofthe anchor guide assembly in the distal direction to achieve axialcompression as will become apparent from the discussion below.

[0071] Push wire actuators have different requirements, than pullactuator systems, such as the ability to propagate a sufficientcompressive force without excessive compression bending or friction.Thus, solid core wires or tubular structures may be preferred, as wellas larger outside diameters compared to the minimum requirements in apull actuated system. Thus, the inside diameter of the actuator lumen 57may be varied, depending upon the actuator system design. In theillustrated embodiment, the actuator lumen 57 has an ID of about 0.038inches, to slideably accommodate the 0.025 inch OD actuator 56.

[0072] A radially outwardly directed force on the anchor supports 62 canbe provided by any of a variety of alternative expansion structures,depending upon desired performance and construction issues. For example,an inflatable balloon can be positioned radially inwardly from aplurality of hingably mounted anchor supports 62, and placed incommunication with actuator lumen 54 which may be used as an inflationlumen. Any of a variety of balloon materials may be used, ranging inphysical properties from latex for a highly compliant, low pressuresystem to PET for a noncompliant high pressure and consequently highradial force system, as is understood in the balloon angioplasty arts.

[0073] The tubular body 52 may additionally be provided with a guidewirelumen 57, or a guidewire lumen 57 may extend coaxially throughout thelength of a tubular actuator 56 as in the illustrated embodiment.

[0074] The tubular body 52 may additionally be provided with adeployment lumen 58, for axially movably receiving one or moredeployment elements 60 such as a wire, or suture for deploying one ormore tissue anchors 90 into the target tissue 110. Deployment force fordeploying the tissue anchors 90 can be designed to be in either thedistal or proximal direction, and many of the considerations discussedabove in connection with the actuator 56 and corresponding actuatorlumen 54 apply to the deployment system as well. In the illustratedembodiment, deployment of the tissue anchors 90 is accomplished byproximal retraction on the deployment element 60 which, in turn,retracts deployment wire 106. Pushability is thus not an issue, andcommon suture such as 0.008 inch diameter nylon line may be used. Forthis embodiment, deployment lumen 58 has an inside diameter of about0.038 inches. The deployment lumen 58 can be sized to receive either asingle deployment element 60, or a plurality of deployment elements 106such as a unique suture for each tissue anchor.

[0075] The distal end 36 of the closure catheter 38 is provided with oneor more anchor supports 62, for removably carrying one or more tissueanchors. Preferably, two or more anchor supports 62 are provided, and,generally, in a device intended for LAA closure, from about 3 to about12 anchor supports 62 are provided. In the illustrated embodiment, sixanchor supports 62 are evenly circumferentially spaced around thelongitudinal axis of the closure catheter 38.

[0076] Each anchor support 62 comprises a surface 63 for slideablyretaining at least one tissue anchor, and permitting the tissue anchorto be aimed by manipulation of a control on the proximal end 50 of theclosure catheter 38. Specific details of one embodiment of the anchorsupport 62 having a single anchor therein will be discussed below.Multiple anchors, such as two or three or more, can also be carried byeach anchor support for sequential deployment.

[0077] The anchor supports 62 are movable between an axial orientationand an inclined orientation, in response to manipulation of a proximalcontrol. The proximal control can take any of a variety of forms, suchas slider switches or levers, rotatable levers or knobs, or the like,depending upon the desired performance. For example, a rotatable knobcontrol can permit precise control over the degree of inclination of theanchor supports 62. A direct axial slider control, such as a knob orother grip directly mounted to the actuator 56 will optimize tactilefeedback of events such as the anchor supports 62 coming into contactwith the target tissue.

[0078] Each of the illustrated anchor supports 62 comprises at least aproximal section 70, a distal section 72, and a flex point 74. See FIG.4. The distal end 73 of each distal section 72 is movably connected tothe catheter body or the cap 68. In this embodiment, proximal retractionof the actuator 56 shortens the axial distance between the proximal end71 of the proximal section 70 and the distal end 73 of distal section72, forcing the flex point 74 radially outwardly from the longitudinalaxis of the closure catheter 38. In this manner, proximal retraction ofthe actuator 56 through a controlled axial distance will cause apredictable and controlled increase in the angle between the proximaland distal sections 70 and 72 of the anchor support 62 and thelongitudinal axis of the catheter. This is ideally suited for aiming aplurality of tissue anchors at the interior wall of a tubular structure,such as a vessel or the left atrial appendage.

[0079] Referring to FIG. 4, there is illustrated an enlarged detailedview of one anchor support 62 in accordance with the present invention.The proximal section 70 and distal section 72 preferably comprise atubular wall 76 and 78 joined at the flex point 74. In one embodiment,the proximal section 70 and distal section 72 may be formed from asingle length of tubing, such as by laser cutting, photolithography, orgrinding to separate the proximal section 70 from the distal section 72while leaving one or two or more integrally formed hinges at flex point74. Any of a variety of polymeric or metal tubing may be utilized forthis purpose, including stainless steel, Nitinol or other super-elasticalloys, polyimide, or others which will be appreciated by those of skillin the art in view of the disclosure herein.

[0080] In the illustrated six tube embodiment, the proximal section 70and distal section 72 are formed from a length of PEEK tubing having aninside diameter of about 0.038 inches, an outside diameter of about0.045 inches and an overall length of about 1.4 inches. In general, ifmore than six anchor supports 62 are used, the diameter of each will becommensurately less than in the six tube embodiment for any particularapplication. When the proximal section 70 and the distal section 72 arecoaxially aligned, a gap having an axial length of about 0.030 isprovided therebetween. In the illustrated embodiment, the proximalsection 70 and distal section 72 are approximately equal in lengthalthough dissimilar lengths may be desirable in certain embodiments. Thelength of the portion of the anchor support 62 which carries the tissueanchor 90 is preferably selected for a particular procedure or anatomyso that the anchor support 62 will be inclined at an acceptable launchangle when the deployment end of the anchor support 62 is brought intocontact with the target tissue 110. Lengths from the hinge to thedeployment end of the anchor support 62 within the range of from about0.5 cm to about 1.5 cm are contemplated for the LAA applicationdisclosed herein.

[0081] For certain applications, the proximal section 70 is at leastabout 10% and preferably at least about 20% longer than the distalsection 72. For example, in one device adapted for the LAA closureapplication, the proximal section 70 in a six anchor device has a lengthof about 0.54 inches, and the distal section 72 has a length of about0.40 inches. Each anchor support has an OD of about 0.045 inches. Aswith previous embodiments, the functional roles and/or the dimensions ofthe proximal and distal sections can be reversed and remain within thescope of the present invention. Optimization of the relative lever armlengths can be determined for each application taking into account avariety of variables such as desired device diameter, target lumen ortissue aperture diameter, launch angle and desired pull forces foraiming and deployment.

[0082] The proximal end 71 of the proximal section 70 and distal end 73of distal section 72 are movably secured to the closure catheter 38 inany of a variety of ways which will be apparent to those of skill in theart in view of the disclosure herein. In the illustrated embodiment,each anchor support 62 comprises a four segment component which may beconstructed from a single length of tubing by providing an intermediateflex point 74, a proximal flex point 80 and a distal flex point 82.Distal flex point 82 provides a pivotable connection between the anchorsupport 62 and a distal connection segment 84. The distal connectionsegment 84 may be secured to the distal end of actuator 56 by any of avariety of techniques, such as soldering, adhesives, mechanical interfitor others, as will be apparent to those of skill in the art. In theillustrated embodiment, the distal connection segment 84 is secured tothe distal end 66 of the actuator 56 by adhesive bonding.

[0083] The proximal flex point 80 in the illustrated embodimentseparates the proximal section 70 from a proximal connection segment 86,which is attached to the catheter body 52. In this construction,proximal axial retraction of the actuator 56 with respect to the tubularbody 52 will cause the distal connection segment 84 to advanceproximally towards the proximal connection segment 86, thereby laterallydisplacing the flex point 74 away from the longitudinal axis of theclosure catheter 38. As a consequence, each of the proximal section 70and the distal section 72 are aimed at an angle which is inclinedoutwardly from the axis of the closure catheter 38.

[0084] In general, each flex point 80, 82 includes a hinge 81, 83 whichmay be, as illustrated, a strip of flexible material. The hinges 81 and83 are preferably positioned on the inside radius of the flex points 80,82, respectively, for many construction materials. For certainmaterials, such as Nitinol or other superelastic alloys, the hinges 81and 83 can be positioned at approximately 90° or 180° or other anglearound the circumference of the tubular anchor guide from the insideradius of the flex point.

[0085] A tissue anchor 90 is illustrated as positioned within the distalsection 72, for deployment in a generally proximal direction.Alternatively, the anchor 90 can be loaded in the proximal section 70,for distal deployment. A variety of tissue anchors can be readilyadapted for use with the closure catheter 38 of the present invention,as will be appreciated by those of skill in the art in view of thedisclosure herein. In the illustrated embodiment, the tissue anchor 90comprises a tubular structure having a body 92, and one or more barbs94. Tubular body 92 is coaxially movably disposed about an introducer96. Introducer 96 has a proximal section 98, and a sharpened distal tip100 separated by an elongate distal section 102 for slideably receivingthe tissue anchor 90 thereon.

[0086] The tissue anchor 90 in the illustrated embodiment comprises atubular body 92 having an axial length of about 0.118 inches, an insidediameter of about 0.017 inches and an outside diameter of about 0.023inches. Two or more barbs 94 may be provided by laser cutting a patternin the wall of the tube, and bending each barb 94 such that it is biasedradially outwardly as illustrated. The tissue anchor 90 may be made fromany of a variety of biocompatible metals such as stainless steel,Nitinol, Elgiloy or others known in the art. Polymeric anchors such asHDPE, nylon, PTFE or others may alternatively be used. For embodimentswhich will rely upon a secondary closure structure such as staples,sutures or clips to retain the LAA or other cavity closed, the anchormay comprise a bioabsorbable or dissolvable material so that itdisappears after a period of time. An anchor suture 108 is secured tothe anchor.

[0087] In one embodiment of the invention, the introducer 96 has anaxial length of about 0.250 inches. The proximal section 98 has anoutside diameter of about 0.023 inches and an axial length of about0.100 inches. The distal section 102 has an outside diameter of about0.016 inches and an axial length of about 0.150 inches. The outsidediameter mismatch between the proximal section 98 and the distal section102 provides a distally facing abutment 104, for supporting the tubularbody 92 of tissue anchor 90, during the tissue penetration step. Adeployment wire (e.g., a suture) 106 is secured to the proximal end 98of the introducer 96. The introducer 96 may be made in any of a varietyof ways, such as extrusion or machining from stainless steel tube stock.

[0088] Referring to FIGS. 6A-6C, introduction of the tissue anchor 90into target tissue 110 is illustrated following inclination of theanchor support 62 with respect to the longitudinal axis of the closurecatheter 38. Proximal retraction of the deployment wire 106 causes thetissue anchor 90 and introducer 96 assembly to travel axially throughthe distal section 72, and into the tissue 110. Continued axial tractionon the deployment wire 106 causes the longitudinal axis of theintroducer 96 to rotate, such that the introducer 96 becomes coaxiallyaligned with the longitudinal axis of the proximal section 70. Continuedproximal traction on the deployment wire 106 retracts the introducer 96from the tissue anchor 90, leaving the tissue anchor 90 in place withinthe tissue. The anchor suture 108 remains secured to the tissue anchor90, as illustrated in FIG. 6C.

[0089] In use, the closure catheter 38 is percutaneously introduced intothe vascular system and transluminally advanced into the heart and,subsequently, into the left atrial appendage using techniques which areknown in the art. Referring to FIG. 7, the distal end 36 of the closurecatheter 38 is positioned at about the opening of the LAA 16, and theposition may be confirmed using fluoroscopy, echocardiography, or otherimaging. The actuator 56 is thereafter proximally retracted, to inclinethe anchor supports 62 radially outwardly from the longitudinal axis ofthe closure catheter 38, as illustrated in FIG. 8. Preferably, the axiallength of the proximal section 70 of each anchor support 62, incombination with the angular range of motion at the proximal flex point80, permit the flex point 74 to be brought into contact with the tissuesurrounding the opening to the LAA. In general, this is preferablyaccomplished with the distal section 72 inclined at an angle within arange of from about 45° to about 120° with respect to the longitudinalaxis of the closure catheter 38. Actuator 56 may be proximally retracteduntil the supports 62 are fully inclined, or until tactile feedbackreveals that the anchor supports 62 have come into contact with thesurrounding tissue 110.

[0090] Following inclination of the anchor supports 62, the deploymentwire 106 is proximally retracted thereby advancing each of the tissueanchors 90 into the surrounding tissue 110 as has been discussed. SeeFIG. 9. The anchor supports 62 are thereafter returned to the first,axial position, as illustrated in FIG. 10, for retraction from the leftatrial appendage. Proximal retraction on the anchor sutures 108 such asthrough a tube, loop or aperture will then cause the left atrialappendage wall to collapse as illustrated in FIG. 11. Anchor sutures maythereafter be secured together using any of a variety of conventionalmeans, such as clips, knots, adhesives, or others which will beunderstood by those of skill in the art. Alternatively, the LAA may besutured, pinned, stapled or clipped shut, or retained using any of avariety of biocompatible adhesives.

[0091] In one embodiment, a single suture 108 is slideably connected toa plurality of anchors such that proximal retraction of the suture 108following deployment of the anchors draws the tissue closed in a “pursestring” fashion. A similar technique is illustrated in FIGS. 31A and 31Bin U.S. Pat. No. 5,865,791 to Whayne, et al., the disclosure of which isincorporated in its entirety herein by reference.

[0092] Depending upon the size and anatomical forces working on theaperture or lumen to be closed, anywhere from 2 to about 12 or moreanchors may be spaced around the circumference of the opening using anyof the deployment catheters disclosed herein. Preferably, from about 3to about 8 anchors, and, in one “purse string” embodiment, six anchorsare utilized in the context of closing an atrial septal defect. However,the precise number and position of the anchors surrounding an atrialseptal defect or other aperture can be varied depending upon theanatomy, and clinical judgement as will be apparent to those of skill inthe art.

[0093] Referring to FIGS. 11A-11C the distal end 36 of a deploymentcatheter is schematically illustrated following deployment of aplurality of anchors 90. Only two anchors are illustrated forsimplicity. An anchor suture 108 extends in a loop 113, and slideablycarries each of the anchors 90. A retention structure 109 is slideablycarried by first and second portions of the anchor suture 108, such thatdistal advancement of the retention structure 109 along the suture 108causes the loop 113 formed by the distal portion of anchor suture 108and retention structure 109 to decrease in circumference, such as wouldbe accomplished during a reduction of the size of the tissue aperture orlumen.

[0094] Preferably, the retention structure 109 may be advanced distallyalong the suture 108 to close the loop 113 such as by proximallyretracting the suture 108 into the deployment catheter and contactingthe retention structure 109 against a distal surface 69 which may be onthe cap 68 or other aspect of the distal end 36 of the catheter. In theillustrated embodiment, the retention structure 109 includes a firstPrusik knot 115 and a second Prusik knot 117, slideably carried on thesuture 108. The first and second Prusik knots 115, 117 are securedtogether such as by a square knot 119. Any of a variety of other knots,links or other connections may alternatively be utilized. The foregoingclosure techniques may be accomplished through the closure catheter, orthrough the use of a separate catheter. The closure catheter maythereafter be proximally retracted from the patient, and thepercutaneous and vascular access sites closed in accordance withconventional puncture closure techniques.

[0095] In accordance with a further aspect of the present invention, theclosure catheter 38 with modifications identified below and/or apparentto those of skill in the art in view of the intended application, may beutilized to close any of a variety of tissue apertures. These include,for example, atrial septal defects, ventricle septal defects, patentductus arteriosis, patent foreman ovale, and others which will beapparent to those of skill in the art. Tissue aperture closuretechniques will be discussed in general in connection with FIGS. 12-17.

[0096] Referring to FIG. 12, there is schematically illustrated afragmentary view of a tissue plane 120 such as a septum or other wall ofthe heart. Tissue plane 120 contains an aperture 122, which is desirablyclosed. The closure catheter 38 is illustrated such that at least aportion of the distal end 36 extends through the aperture 122. Althoughthe present aspect of the invention will be described in terms of aretrograde or proximal tissue anchor advancement from the back side ofthe tissue plane, the anchor deployment direction can readily bereversed by one of ordinary skill in the art in view of the disclosureherein, and the modifications to the associated method would be apparentin the context of a distal anchor advancement embodiment. In general,the proximal anchor advancement method, as illustrated, may desirablyassist in centering of the catheter within the aperture, as well aspermitting positive traction to be in the same direction as anchordeployment.

[0097] Closure catheter 38 is provided with a plurality of anchorsupports 62 as have been described previously herein. In an embodimentintended for atrial septal defect closure, anywhere within the range offrom about 3 to about 12 anchor supports 62 may be utilized.

[0098] Referring to FIG. 13, each anchor support 62 comprises a proximalsection 70, a distal section 72, and a hinge or flex point 74therebetween as has been previously discussed. At least one anchor 90 iscarried by each anchor support 62, such as within the tubular distalsection 72 in the context of a proximal deployment direction embodiment.Anchor 90 is connected to an anchor suture 108 as has been discussed. Inthe illustrated embodiment, the anchor suture 108 extends along theoutside of the anchor support 62 and into the distal opening of a lumenin tubular body 52. The anchor sutures 108 may, at some point, be joinedinto a single element, or distinct anchor sutures 108 may extendthroughout the length of the catheter body to the proximal end thereof.

[0099] As shown in FIG. 13, the anchor support 62 is advanced from agenerally axially extending orientation to an inclined orientation tofacilitate deployment of the anchor 90 into the tissue plane 120adjacent aperture 122. Preferably, the geometry of the triangle definedby distal section 72, proximal section 70 and the longitudinal axis ofthe catheter is selected such that the plurality of anchors 90 willdefine a roughly circular pattern which has a greater diameter than thediameter of aperture 122. Thus, the length of proximal section 70 willgenerally be greater than the approximate radius of the aperture 122.

[0100] In general, for atrial septal defect applications, the circlewhich best fits the anchor deployment pattern when the distal section 72is inclined to its operative angle will have a diameter within the rangeof from about 0.5 centimeters to about 3 centimeters. Dimensions beyondeither end of the foregoing range may be desirable to correct defects ofunusual proportions. In addition, it is not necessary that the anchorsdefine a circular pattern when deployed into the tissue plane 120.Non-circular patterns such as polygonal, elliptical, oval or other, maybe desirable, depending upon the nature of the aperture 122 to beclosed.

[0101]FIG. 13 illustrates the anchors 90 partially deployed into orthrough the tissue plane 120. In general, the anchors 90 may either bedesigned to reside within the tissue plane 120 such as for locations ofthe aperture 120 which are adjacent relatively thick tissues.Alternatively, the tissue anchor 90 may be designed to reside on oneside of the tissue plane 120, and attached to a suture which extendsthrough the tissue plane 120 as illustrated in FIGS. 14 and 15.

[0102] Referring to FIG. 14, the closure catheter 38 is illustrated asreturned to the generally axial orientation and proximally retractedthrough the aperture 122 following deployment of a plurality of tissueanchors 90. The anchor sutures 108 may thereafter be proximallyretracted from the proximal end of the closure catheter 38, therebydrawing the tissue surrounding aperture 122 together to close theaperture. The anchor sutures 108 may thereafter be secured together inany of a variety of manners, such as by clamping, knotting, adhesives,thermal bonding or the like.

[0103] In the illustrated embodiment, the closure catheter 38 carries adetachable clamp 124 which may be deployed from the distal end of theclosure catheter 38 such as by a push wire, to retain the anchor sutures108. The clamp 124 may be an annular structure with an aperture thereinfor receiving the anchor sutures 108. The clamp is carried on thecatheter in an “open” position and biased towards a “closed” position inwhich it tightens around the sutures 108. A ring of elastomeric polymer,a relatively inelastic but tightenable loop such as a ligating band, ora shape memory metal alloy may be used for this purpose. Any of avariety of clamps, clips, adhesives, or other structures may be utilizedto secure the anchor sutures 108 as will be appreciated by those ofskill in the art in view of the disclosure herein. Anchor sutures 108may thereafter be severed such as by mechanical or thermal means, andthe closure catheter 38 is thereafter retracted from the treatment site.

[0104] Alternatively, elastic bands or other forms of the clamp may bedeployed to directly clamp the tissue and hold the aperture closed. Inthis application, the closure catheter is used to attach a plurality ofanchors spaced around the circumference of the aperture. The anchors aredrawn radially inwardly towards each other by proximal traction on oneor more sutures. Further proximal traction on the one or more suturespulls the aperture edges proximally out of the tissue plane. Thepartially everted aperture can then be secured closed by deploying aclamp there around. As used herein, “clamp” includes all of the elasticband, ligating band, metal clips and other embodiments disclosed herein.

[0105] In accordance with a further aspect of the present invention, theclosure catheter 38 is provided with a deployable patch 126, asillustrated in FIGS. 16 and 17. The patch 126 may comprise of any of avariety of materials, such as PTFE, Dacron, or others depending upon theintended use. Suitable fabrics are well-known in the medical device art,such as those used to cover endovascular grafts or other prostheticdevices.

[0106] The patch 126 is preferably carried by the distal sections 72 ofthe anchor support 62. In the illustrated embodiment, the tissue anchors90 are carried within the proximal section 70 of anchor support 62. Inthis manner, as illustrated in FIG. 17, the patch 126 is automaticallyunfolded and positioned across the aperture 122 as the anchor supports62 are inclined into the anchor deployment orientation. The tissueanchor 90 may thereafter be advanced through the patch 126 and into thetissue plane 120 to tack the patch 126 against the opening 122.Alternatively, the tissue anchors may be deployed in a pattern whichsurrounds but does not penetrate the tissue patch. In this embodiment,the tissue anchors are preferably connected to the tissue patch such asby a suture. The tissue anchors may also both be connected to the patchor to each other by sutures and penetrated through the patch into thetarget tissue.

[0107] Tissue anchors 90 may be deployed proximally by pulling thedeployment wire 106. Alternatively, tissue anchors 90 with or without ananchor suture 108, may be deployed from the proximal section 70 by apush wire axially movably positioned within the proximal section 70.Tissue anchors 90 may be carried on an introducer 96 as has beendiscussed previously herein.

[0108] The patch 126 may be retained on the distal section 72 in any ofa variety of ways, such as through the use of low strength adhesivecompositions, or by piercing the anchors 90 through the material of thepatch 126 during the catheter assembly process.

[0109] The cardiac defects may be accessed via catheter through avariety of pathways. An ASD or VSD may be accessed from the arterialcircuit. The catheter is introduced into the arterial vascular systemand guided up the descending thoracic and/or abdominal aorta. Thecatheter may then be advanced into the left ventricle (LV) through theaortic outflow tract. Once in the LV, the closure anchors may bedeployed in the VSD. Alternatively, once in the LV, the catheter may bedirected up through the mitral valve and into the left atrium (LA). Whenthe catheter is in the LA, it may be directed into the ASD and theanchors deployed.

[0110] Alternatively, an ASD or VSD may be accessed from the venouscircuit. The catheter may be introduced into the venous system, advancedinto the Inferior Vena Cava (IVC) or Superior Vena Cava (SVC) and guidedinto the right atrium (RA). The catheter may then be directed into theASD. Alternatively, once in the RA, the catheter may be advanced throughthe tricuspid valve and into the right ventricle (RV) and directed intothe VSD and the anchors deployed.

[0111] Referring to FIGS. 18A-18G, there are illustrated a variety oftissue anchors which may be used in the tissue closure or attachmentdevice of the present invention. Each of FIGS. 18A and 18B disclose ananchor having a body 92, a distal tip 101, and one or more barbs 94 toresist proximal movement of the anchor. An aperture 107 is provided toreceive the anchor suture. The embodiments of FIGS. 18A and 18B can bereadily manufactured such as by stamping or cutting out of flat sheetstock.

[0112] The anchor illustrated in FIG. 18C comprises a wire having a body92 and a distal tip 101. The wire preferably comprises a super-elasticalloy such as Nitinol or other nickel titanium-based alloy. The anchoris carried within a tubular introducer, in a straight orientation, forintroduction into the tissue where the anchor is to reside. As the body92 is advanced distally from the carrier tube, the anchor resumes itslooped distal end configuration within the tissue, to resist proximalretraction on the wire body 92.

[0113]FIG. 18D illustrates a tubular anchor, which may be manufacturedfrom a section of hypotube, or in the form of a flat sheet which isthereafter rolled about a mandrel and soldered or otherwise secured. Theanchor comprises a distal tip 101, one or more barbs 94, and an aperture107 for securing the anchor suture. The anchor of FIG. 18D may becarried by and deployed from the interior of a tubular anchor support ashas been discussed. Alternatively, the anchor of FIG. 18D can becoaxially positioned over a central tubular or solid anchor supportwire.

[0114]FIG. 18E illustrates an anchor which may be formed either bycutting from tube stock or by cutting a flat sheet such as illustratedin FIG. 18F which is thereafter rolled about an axis and soldered orotherwise secured into a tubular body. In this embodiment, three distaltips 101 in the flat sheet stock may be formed into a single distal tip101 in the finished anchor as illustrated in FIG. 18E. One or more barbs94 may be formed by slotting the sheet in a U or V-shaped configurationas illustrated. The anchor in FIG. 18E is additionally provided with oneor more barbs 95 which resist distal migration of the anchor. This maybe desirable where the anchor is implanted across a thin membrane, or inother applications where distal as well as proximal migration isdesirably minimized.

[0115] Although the present invention has been described in terms ofcertain preferred embodiments, other embodiments will become apparent tothose of skill in the art in view of the disclosure herein. Accordingly,the scope of the invention is not intended to be limited by the specificdisclosed embodiments, but, rather, by the attached claims.

What is claimed is:
 1. A method of closing an opening in a wall of theheart, comprising the steps of: providing a catheter having at leastfour tissue anchors thereon, the tissue anchors each having a suturesecured thereto; advancing the catheter to the opening in the wall ofthe heart; inclining the anchors outwardly from the axis of the catheterto aim the anchors at tissue surrounding the opening; deploying theanchors into tissue surrounding the opening; and manipulating theanchors to reduce the size of the opening.
 2. A method of closing anopening in a wall of the heart as in claim 1 , wherein the deploying theanchors step comprises deploying the anchors in a proximal direction. 3.A method of closing an opening in a wall of the heart as in claim 1 ,wherein the deploying the anchors step comprises deploying the anchorsin a distal direction.
 4. A method of closing an opening in a wall ofthe heart as in claim 1 , wherein at least some of the tissue anchorshave a suture slideably attached thereto.
 5. A method of closing anopening in a wall of the heart as in claim 4 , wherein the manipulatingthe anchors step comprises proximally retracting at least one suture todraw the opening closed.
 6. A method of closing an opening in a wall ofthe heart as in claim 5 , further comprising the step of deploying aclamp to hold the opening closed.
 7. A method of closing an opening in awall of the heart as in claim 6 , wherein the deploying a clamp stepcomprises deploying an elastic band.
 8. A method of closing an openingin a wall of the heart as in claim 6 , wherein the deploying a clampstep comprises deploying a metal clamp.